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Making Activity Time for Cognitive Health (MATCH)

Primary Purpose

Breast Cancer, Cancer-related Problem/Condition, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walking for 10 minutes
Walking for 20 minutes
Walking for 30 minutes
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • women over the age of 18
  • diagnosis of breast cancer
  • no longer undergoing treatment
  • fluent in English
  • no history of dementia or organic brain syndrome
  • not currently pregnant
  • able to walk unassisted
  • no health reasons that would prevent ability to exercise
  • not currently enrolled in another exercise research study
  • reported trouble with memory/concentration
  • physician's consent

Exclusion Criteria:

  • male
  • no diagnosis of breast cancer
  • under 18 years of age
  • currently undergoing treatment for breast cancer
  • inability to communicate in English
  • history of dementia or organic brain syndrome
  • pregnant
  • unable to walk unassisted
  • other health reasons that may prevent ability to exercise
  • enrolled in another exercise research study
  • no reported trouble with memory or concentration
  • non-consent of physician

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    10-minute Treadmill Walking

    20-minute Treadmill Walking

    30-minute Treadmill Walking

    Arm Description

    All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session. Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.

    All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session. Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.

    All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session. Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.

    Outcomes

    Primary Outcome Measures

    Change in working memory by walking as a function of walking duration (10, 20 or 30 minutes)
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of a working memory task (Spatial Working Memory domain). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Change in attention by walking as a function of walking duration (10, 20 or 30 minutes)
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of an attention task (Flanker task). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Change in cognitive flexibility by walking as a function of walking duration (10, 20 or 30 minutes)
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of a cognitive flexibility task (Task Switching Paradigm). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Change in processing speed by walking as a function of walking duration (10, 20 or 30 minutes)
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of a processing speed task (Letter Comparison task). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.

    Secondary Outcome Measures

    Lifestyle physical activity as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
    Investigators are interested in determining what lifestyle factors are associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise. Lifestyle physical activity will be measured via accelerometer in units of average minutes per day. Higher values indicate greater levels of lifestyle physical activity.
    Mental health as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
    Investigators are interested in determining what mental health factors are associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise. Mental health factors of interest are anxiety and depression as measured via the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scores range from 0-21 with higher scores indicating increased anxiety and depression.
    Body mass index as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
    Investigators are interested in determining is body mass index associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise. Body mass index will be measured using the standard kilograms/meters^2. Increased body mass index indicates worsened health.
    Change from baseline in anxiety levels after one bout of exercise as assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire.
    Participants will complete a short anxiety questionnaire before and after a 30 minute bout of aerobic exercise. The investigators will then compare the pre- and post- values to examine if any changes are present. Scores on the HADS range from 0-21 with higher scores indicating increased anxiety and depression.

    Full Information

    First Posted
    January 29, 2020
    Last Updated
    February 7, 2020
    Sponsor
    University of Illinois at Urbana-Champaign
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04255225
    Brief Title
    Making Activity Time for Cognitive Health
    Acronym
    MATCH
    Official Title
    Making Activity Time for Cognitive Health (MATCH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Urbana-Champaign

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Approximately 75% of cancer survivors experience some degree of cognitive deficit throughout their cancer experience, with upwards of one third of breast cancer survivors reporting impairments up to a decade after treatment. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function. The investigators recently reported on the beneficial effects of acute exercise, or single sessions of physical activity, on processing speed and spatial working memory in breast cancer survivors, suggesting that acute bouts of physical activity may mitigate select domains of CRCI. Specifically, survivors in this study demonstrated faster processing speed, and trended towards faster and more accurate spatial working memory, after thirty minutes of moderate-intensity walking compared to seated rest. But half an hour of walking may be challenging to certain subgroups of survivors, particularly those who are deconditioned or with significant barriers to longer walks. With a renewed focus on un-bouted physical activity and avoiding inactivity during survivorship, it is important to better understand the dose or volume of exercise responsible for providing breast cancer survivors with the greatest cognitive benefits. The investigators examined the effects of varying durations of exercise (e.g., 10, 20 and 30 minutes) on cognitive function in breast cancer survivors to identify the optimal length of acute exercise. Findings from this study will inform new guidelines for acute exercise after cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Cancer-related Problem/Condition, Cognitive Impairment, Physical Activity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    10-minute Treadmill Walking
    Arm Type
    Experimental
    Arm Description
    All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session. Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.
    Arm Title
    20-minute Treadmill Walking
    Arm Type
    Experimental
    Arm Description
    All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session. Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.
    Arm Title
    30-minute Treadmill Walking
    Arm Type
    Experimental
    Arm Description
    All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session. Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walking for 10 minutes
    Intervention Description
    Participants will walk on a treadmill for 10 minutes at a moderate intensity.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walking for 20 minutes
    Intervention Description
    Participants will walk on a treadmill for 20 minutes at a moderate intensity.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walking for 30 minutes
    Intervention Description
    Participants will walk on a treadmill for 30 minutes at a moderate intensity.
    Primary Outcome Measure Information:
    Title
    Change in working memory by walking as a function of walking duration (10, 20 or 30 minutes)
    Description
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of a working memory task (Spatial Working Memory domain). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Time Frame
    1 year
    Title
    Change in attention by walking as a function of walking duration (10, 20 or 30 minutes)
    Description
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of an attention task (Flanker task). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Time Frame
    1 year
    Title
    Change in cognitive flexibility by walking as a function of walking duration (10, 20 or 30 minutes)
    Description
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of a cognitive flexibility task (Task Switching Paradigm). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Time Frame
    1 year
    Title
    Change in processing speed by walking as a function of walking duration (10, 20 or 30 minutes)
    Description
    All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly. Prior to each session, participants will complete a cognitive battery consisting of a processing speed task (Letter Comparison task). They will then complete the same cognitive battery immediately after the session. Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Lifestyle physical activity as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
    Description
    Investigators are interested in determining what lifestyle factors are associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise. Lifestyle physical activity will be measured via accelerometer in units of average minutes per day. Higher values indicate greater levels of lifestyle physical activity.
    Time Frame
    1 year
    Title
    Mental health as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
    Description
    Investigators are interested in determining what mental health factors are associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise. Mental health factors of interest are anxiety and depression as measured via the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scores range from 0-21 with higher scores indicating increased anxiety and depression.
    Time Frame
    1 year
    Title
    Body mass index as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
    Description
    Investigators are interested in determining is body mass index associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise. Body mass index will be measured using the standard kilograms/meters^2. Increased body mass index indicates worsened health.
    Time Frame
    1 year
    Title
    Change from baseline in anxiety levels after one bout of exercise as assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire.
    Description
    Participants will complete a short anxiety questionnaire before and after a 30 minute bout of aerobic exercise. The investigators will then compare the pre- and post- values to examine if any changes are present. Scores on the HADS range from 0-21 with higher scores indicating increased anxiety and depression.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    All participants will be female breast cancer survivors.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: women over the age of 18 diagnosis of breast cancer no longer undergoing treatment fluent in English no history of dementia or organic brain syndrome not currently pregnant able to walk unassisted no health reasons that would prevent ability to exercise not currently enrolled in another exercise research study reported trouble with memory/concentration physician's consent Exclusion Criteria: male no diagnosis of breast cancer under 18 years of age currently undergoing treatment for breast cancer inability to communicate in English history of dementia or organic brain syndrome pregnant unable to walk unassisted other health reasons that may prevent ability to exercise enrolled in another exercise research study no reported trouble with memory or concentration non-consent of physician

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32760319
    Citation
    Salerno EA, Rowland K, Hillman CH, Trinh L, Kramer AF, McAuley E. Dose-Response Effects of Acute Aerobic Exercise Duration on Cognitive Function in Patients With Breast Cancer: A Randomized Crossover Trial. Front Psychol. 2020 Jul 14;11:1500. doi: 10.3389/fpsyg.2020.01500. eCollection 2020.
    Results Reference
    derived

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    Making Activity Time for Cognitive Health

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